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Trial record 3 of 6 for:    ACTT | covid

Adaptive COVID-19 Treatment Trial (ACTT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280705
Recruitment Status : Completed
First Posted : February 21, 2020
Results First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition COVID-19
Interventions Other: Placebo
Drug: Remdesivir
Enrollment 1062
Recruitment Details Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between 21FEB2020 and 20APR2020.
Pre-assignment Details  
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description

200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.

Placebo: The supplied placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a placebo of normal saline of equal volume may be given if there are limitations on matching placebo supplies.

200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.

Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.

Period Title: Overall Study
Started 521 541
Received Treatment 517 531
Completed 508 517
Not Completed 13 24
Reason Not Completed
Enrolled but not treated             4             10
Physician Decision             1             0
Withdrawal by Subject             7             9
Adverse Event             0             4
Transferred to another hospital             1             1
Arm/Group Title Placebo Remdesivir Total
Hide Arm/Group Description 200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course. Total of all reporting groups
Overall Number of Baseline Participants 521 541 1062
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 541 participants 1062 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
324
  62.2%
354
  65.4%
678
  63.8%
>=65 years
197
  37.8%
187
  34.6%
384
  36.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 521 participants 541 participants 1062 participants
59.2  (15.4) 58.6  (14.6) 58.9  (15.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 541 participants 1062 participants
Female
189
  36.3%
189
  34.9%
378
  35.6%
Male
332
  63.7%
352
  65.1%
684
  64.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 541 participants 1062 participants
Hispanic or Latino
116
  22.3%
134
  24.8%
250
  23.5%
Not Hispanic or Latino
373
  71.6%
382
  70.6%
755
  71.1%
Unknown or Not Reported
32
   6.1%
25
   4.6%
57
   5.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 541 participants 1062 participants
American Indian or Alaska Native
3
   0.6%
4
   0.7%
7
   0.7%
Asian
56
  10.7%
79
  14.6%
135
  12.7%
Native Hawaiian or Other Pacific Islander
2
   0.4%
2
   0.4%
4
   0.4%
Black or African American
117
  22.5%
109
  20.1%
226
  21.3%
White
287
  55.1%
279
  51.6%
566
  53.3%
More than one race
1
   0.2%
2
   0.4%
3
   0.3%
Unknown or Not Reported
55
  10.6%
66
  12.2%
121
  11.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 521 participants 541 participants 1062 participants
Greece 19 14 33
South Korea 12 9 21
Singapore 7 9 16
United States 410 427 837
Japan 7 8 15
Denmark 21 22 43
Mexico 6 4 10
United Kingdom 21 25 46
Germany 6 7 13
Spain 12 16 28
Disease severity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 541 participants 1062 participants
Mild-to-moderate disease severity
50
   9.6%
55
  10.2%
105
   9.9%
Severe disease severity
471
  90.4%
486
  89.8%
957
  90.1%
[1]
Measure Description:

Mild-moderate disease: SpO2 > 94% and respiratory rate < 24 breaths/min without supplemental oxygen.

Severe disease: requiring mechanical ventilation, requiring oxygen, a SpO2 = 94% on room air, or tachypnea (respiratory rate = 24 breaths/min).

1.Primary Outcome
Title Time to Recovery
Hide Description Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Median (95% Confidence Interval)
Unit of Measure: Days
15
(13 to 18)
10
(9 to 11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Remdesivir
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
1.12 to 1.49
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Alanine Transaminase (ALT)
Hide Description Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 463 465
Mean (Standard Deviation)
Unit of Measure: Units/Liter (U/L)
Day 3 Number Analyzed 463 participants 465 participants
14.3  (88) 2.9  (31.5)
Day 5 Number Analyzed 403 participants 398 participants
23.1  (70.6) 10.8  (55.8)
Day 8 Number Analyzed 327 participants 296 participants
24.2  (79.7) 8.9  (54.2)
Day 11 Number Analyzed 257 participants 227 participants
27.7  (89.8) 3.4  (48.4)
Day 15 Number Analyzed 242 participants 257 participants
28.1  (110.1) 1.7  (47.4)
Day 29 Number Analyzed 180 participants 220 participants
-3.9  (62.2) -6.8  (43.7)
3.Secondary Outcome
Title Change From Baseline in Aspartate Transaminase (AST)
Hide Description Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 438 445
Mean (Standard Deviation)
Unit of Measure: Units/Liter (U/L)
Day 3 Number Analyzed 438 participants 445 participants
13.7  (90.7) -2.0  (29.1)
Day 5 Number Analyzed 384 participants 380 participants
12.8  (66.2) 6.0  (58.9)
Day 8 Number Analyzed 315 participants 285 participants
13.1  (114.6) 1.1  (55.9)
Day 11 Number Analyzed 247 participants 219 participants
11.5  (78.8) -0.3  (51.7)
Day 15 Number Analyzed 236 participants 248 participants
4.2  (73.0) -2.3  (60.4)
Day 29 Number Analyzed 170 participants 208 participants
-18.4  (47.2) -14.0  (52.2)
4.Secondary Outcome
Title Change From Baseline in Creatinine
Hide Description Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 475 482
Mean (Standard Deviation)
Unit of Measure: milligrams/deciliter (mg/dL)
Day 3 Number Analyzed 475 participants 482 participants
0.037  (0.517) 0.038  (0.569)
Day 5 Number Analyzed 418 participants 411 participants
-0.695  (17.552) 0.075  (0.762)
Day 8 Number Analyzed 335 participants 309 participants
-0.882  (19.637) 0.158  (0.951)
Day 11 Number Analyzed 269 participants 234 participants
1.173  (15.440) 0.236  (1.057)
Day 15 Number Analyzed 249 participants 262 participants
-1.239  (22.755) 0.319  (2.147)
Day 29 Number Analyzed 189 participants 229 participants
-1.863  (26.093) 0.075  (0.644)
5.Secondary Outcome
Title Change From Baseline in Glucose
Hide Description Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 456 459
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 3 Number Analyzed 456 participants 459 participants
-0.2  (53.4) -3.0  (49.4)
Day 5 Number Analyzed 407 participants 395 participants
6.3  (60.2) 2.1  (63.8)
Day 8 Number Analyzed 323 participants 301 participants
2.2  (73.3) 3.2  (68.0)
Day 11 Number Analyzed 260 participants 228 participants
1.0  (70.1) -0.1  (77.4)
Day 15 Number Analyzed 241 participants 250 participants
-2.8  (64.4) -2.9  (75.4)
Day 29 Number Analyzed 180 participants 219 participants
-13.5  (96.8) -11.7  (75.4)
6.Secondary Outcome
Title Change From Baseline in Hemoglobin
Hide Description Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 475 475
Mean (Standard Deviation)
Unit of Measure: grams/deciliter (g/dL)
Day 3 Number Analyzed 475 participants 475 participants
-0.52  (1.10) -0.69  (5.36)
Day 5 Number Analyzed 420 participants 406 participants
-0.83  (1.22) -0.99  (5.83)
Day 8 Number Analyzed 334 participants 310 participants
-1.22  (1.42) -0.49  (6.54)
Day 11 Number Analyzed 269 participants 230 participants
-1.66  (1.67) -1.29  (1.93)
Day 15 Number Analyzed 253 participants 260 participants
-1.51  (2.02) -1.02  (3.04)
Day 29 Number Analyzed 189 participants 227 participants
-1.02  (2.38) -1.21  (7.91)
7.Secondary Outcome
Title Change From Baseline in Platelets
Hide Description Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 471 474
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 471 participants 474 participants
39.3  (60.0) 46.0  (62.6)
Day 5 Number Analyzed 419 participants 403 participants
76.5  (100.5) 90.1  (99.9)
Day 8 Number Analyzed 332 participants 308 participants
111.8  (137.4) 130.8  (128.1)
Day 11 Number Analyzed 269 participants 229 participants
109.3  (149.3) 101.0  (145.0)
Day 15 Number Analyzed 252 participants 258 participants
96.5  (154.2) 71.1  (133.3)
Day 29 Number Analyzed 189 participants 224 participants
32.7  (124.2) 39.6  (107.4)
8.Secondary Outcome
Title Change From Baseline in Prothrombin Time (PT)
Hide Description Blood to evaluate PT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 339 352
Mean (Standard Deviation)
Unit of Measure: seconds
Day 3 Number Analyzed 339 participants 352 participants
-0.18  (4.28) 0.44  (5.22)
Day 5 Number Analyzed 296 participants 306 participants
-0.30  (4.72) 1.15  (5.72)
Day 8 Number Analyzed 246 participants 234 participants
0.01  (2.59) 1.43  (3.89)
Day 11 Number Analyzed 199 participants 182 participants
0.86  (7.85) 1.88  (5.68)
Day 15 Number Analyzed 176 participants 193 participants
0.34  (4.33) -0.03  (4.25)
Day 29 Number Analyzed 134 participants 163 participants
-0.28  (3.20) -0.63  (3.37)
9.Secondary Outcome
Title Change From Baseline in Total Bilirubin
Hide Description Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 451 456
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 3 Number Analyzed 451 participants 456 participants
0.08  (1.25) -0.04  (0.75)
Day 5 Number Analyzed 394 participants 389 participants
0.58  (4.13) -0.03  (1.03)
Day 8 Number Analyzed 315 participants 288 participants
0.22  (2.56) 0.01  (1.38)
Day 11 Number Analyzed 247 participants 220 participants
0.23  (2.79) 0.07  (1.48)
Day 15 Number Analyzed 237 participants 254 participants
0.00  (1.80) 0.09  (1.54)
Day 29 Number Analyzed 178 participants 216 participants
-0.17  (1.65) -0.12  (1.77)
10.Secondary Outcome
Title Change From Baseline in White Blood Cell Count (WBC)
Hide Description Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 474 475
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 474 participants 475 participants
18.691  (424.837) -18.970  (301.944)
Day 5 Number Analyzed 419 participants 405 participants
9.886  (566.175) -28.209  (412.615)
Day 8 Number Analyzed 333 participants 310 participants
27.223  (479.095) -45.997  (602.461)
Day 11 Number Analyzed 268 participants 230 participants
1.967  (16.042) -34.702  (574.065)
Day 15 Number Analyzed 252 participants 260 participants
56.311  (620.551) -70.884  (600.011)
Day 29 Number Analyzed 189 participants 226 participants
-0.898  (17.801) 0.251  (3.987)
11.Secondary Outcome
Title Change From Baseline in Neutrophils
Hide Description Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 463 459
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 463 participants 459 participants
9.429  (260.345) -8.093  (135.068)
Day 5 Number Analyzed 406 participants 389 participants
4.177  (362.782) -15.067  (216.532)
Day 8 Number Analyzed 317 participants 298 participants
17.916  (305.321) -28.179  (365.099)
Day 11 Number Analyzed 257 participants 220 participants
3.010  (27.502) -21.773  (354.025)
Day 15 Number Analyzed 241 participants 253 participants
36.024  (389.093) -39.988  (333.088)
Day 29 Number Analyzed 177 participants 218 participants
-1.269  (7.160) -0.840  (3.666)
12.Secondary Outcome
Title Change From Baseline in Lymphocytes
Hide Description Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 463 459
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 463 participants 459 participants
5.883  (118.740) -7.847  (131.548)
Day 5 Number Analyzed 406 participants 389 participants
4.064  (141.580) -11.723  (167.428)
Day 8 Number Analyzed 317 participants 299 participants
8.006  (137.149) -15.455  (194.111)
Day 11 Number Analyzed 257 participants 220 participants
0.393  (1.371) -12.016  (183.060)
Day 15 Number Analyzed 241 participants 253 participants
14.793  (159.583) -23.836  (218.653)
Day 29 Number Analyzed 177 participants 218 participants
0.668  (1.406) 0.743  (0.664)
13.Secondary Outcome
Title Change From Baseline in Monocytes
Hide Description Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 463 458
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 463 participants 458 participants
2.448  (41.304) -2.940  (46.752)
Day 5 Number Analyzed 406 participants 388 participants
1.498  (57.686) -2.628  (39.329)
Day 8 Number Analyzed 316 participants 299 participants
2.324  (36.626) -3.645  (48.636)
Day 11 Number Analyzed 257 participants 220 participants
0.383  (0.744) -2.539  (43.454)
Day 15 Number Analyzed 241 participants 253 participants
6.475  (69.019) -8.738  (74.365)
Day 29 Number Analyzed 177 participants 218 participants
0.125  (0.485) 0.117  (0.340)
14.Secondary Outcome
Title Change From Baseline in Basophils
Hide Description Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 455 452
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 455 participants 452 participants
0.020  (0.257) 0.005  (0.043)
Day 5 Number Analyzed 394 participants 380 participants
0.038  (0.501) 0.005  (0.370)
Day 8 Number Analyzed 309 participants 293 participants
0.196  (3.132) 0.005  (0.368)
Day 11 Number Analyzed 253 participants 218 participants
0.024  (0.042) 0.028  (0.053)
Day 15 Number Analyzed 235 participants 248 participants
0.158  (1.913) -0.058  (1.028)
Day 29 Number Analyzed 176 participants 216 participants
0.040  (0.073) 0.029  (0.054)
15.Secondary Outcome
Title Change From Baseline in Eosinophils
Hide Description Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 456 455
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 456 participants 455 participants
0.634  (10.614) 0.016  (0.727)
Day 5 Number Analyzed 397 participants 387 participants
0.666  (11.977) -0.066  (2.807)
Day 8 Number Analyzed 311 participants 293 participants
0.596  (8.875) -0.221  (4.108)
Day 11 Number Analyzed 254 participants 218 participants
0.093  (0.190) -0.088  (2.973)
Day 15 Number Analyzed 237 participants 251 participants
1.992  (20.365) -0.420  (5.378)
Day 29 Number Analyzed 176 participants 217 participants
0.241  (0.324) 0.211  (0.267)
16.Secondary Outcome
Title Change in National Early Warning Score (NEWS) From Baseline
Hide Description The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.
Time Frame Days 1, 3, 5, 8, 11, 15, 22, and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized with data at baseline and at each timepoint.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 499 502
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 3 Number Analyzed 499 participants 502 participants
0.1  (2.8) -0.3  (2.6)
Day 5 Number Analyzed 447 participants 438 participants
0.3  (3.3) -0.4  (2.9)
Day 8 Number Analyzed 348 participants 321 participants
-0.3  (3.8) -0.5  (3.2)
Day 11 Number Analyzed 291 participants 254 participants
-0.3  (4.1) -0.5  (3.5)
Day 15 Number Analyzed 290 participants 301 participants
-1.4  (4.2) -1.7  (3.6)
Day 22 Number Analyzed 151 participants 120 participants
-1.4  (4.0) -1.7  (4.1)
Day 29 Number Analyzed 221 participants 251 participants
-3.2  (4.0) -3.3  (3.2)
17.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
0
(0 to 1)
0
(0 to 1)
Hospitalized, on invasive mech. vent. or ECMO
30
(26 to 34)
24
(21 to 28)
Hospitalized, on non-invasive vent./high flow O2
19
(16 to 22)
18
(15 to 21)
Hospitalized, requiring supplemental oxygen
39
(35 to 43)
43
(39 to 47)
Hospitalized, not on O2, requiring ongoing care
12
(10 to 15)
14
(11 to 17)
Hospitalized, not requiring O2, no longer req care
0
(0 to 1)
0
(0 to 1)
Not hospitalized, limit on activities/req home O2
0
(0 to 1)
0
(0 to 1)
Not hospitalized, no limitations on activities
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Hospitalized
0
(0 to 1)
1
(0 to 2)
No clinical status score reported - Discharged
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Discontinued
1
(0 to 2)
1
(0 to 2)
18.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
1
(1 to 3)
1
(0 to 2)
Hospitalized, on invasive mech. vent. or ECMO
36
(32 to 40)
28
(25 to 32)
Hospitalized, on non-invasive vent./high flow O2
17
(14 to 21)
16
(13 to 19)
Hospitalized, requiring supplemental oxygen
32
(29 to 37)
37
(33 to 41)
Hospitalized, not on O2, requiring ongoing care
12
(9 to 15)
13
(10 to 16)
Hospitalized, not requiring O2, no longer req care
0.4
(0 to 1)
0.2
(0 to 1)
Not hospitalized, limit on activities/req home O2
0
(0 to 1)
0
(0 to 1)
Not hospitalized, no limitations on activities
0
(0 to 1)
0.4
(0 to 1)
No clinical status score reported - Hospitalized
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Discharged
0.2
(0 to 1)
2
(1 to 4)
No clinical status score reported - Discontinued
1
(0 to 2)
2
(1 to 4)
19.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
2
(1 to 4)
2
(1 to 4)
Hospitalized, on invasive mech. vent. or ECMO
37
(33 to 41)
28
(24 to 32)
Hospitalized, on non-invasive vent./high flow O2
14
(12 to 18)
12
(9 to 15)
Hospitalized, requiring supplemental oxygen
26
(23 to 30)
28
(24 to 31)
Hospitalized, not on O2, requiring ongoing care
11
(8 to 13)
15
(12 to 18)
Hospitalized, not requiring O2, no longer req care
1
(0 to 2)
1
(0 to 2)
Not hospitalized, limit on activities/req home O2
0
(0 to 1)
0.2
(0 to 1)
Not hospitalized, no limitations on activities
0.2
(0 to 1)
0
(0 to 1)
No clinical status score reported - Hospitalized
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Discharged
7
(5 to 9)
12
(9 to 15)
No clinical status score reported - Discontinued
2
(1 to 3)
3
(2 to 5)
20.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
7
(5 to 9)
3
(2 to 5)
Hospitalized, on invasive mech. vent. or ECMO
33
(29 to 37)
24
(21 to 28)
Hospitalized, on non-invasive vent./high flow O2
9
(7 to 12)
9
(7 to 12)
Hospitalized, requiring supplemental oxygen
15
(13 to 19)
17
(14 to 21)
Hospitalized, not on O2, requiring ongoing care
10
(8 to 13)
11
(9 to 14)
Hospitalized, not requiring O2, no longer req care
1
(1 to 3)
1
(1 to 3)
Not hospitalized, limit on activities/req home O2
0
(0 to 1)
0.2
(0 to 1)
Not hospitalized, no limitations on activities
0.2
(0 to 1)
0
(0 to 1)
No clinical status score reported - Hospitalized
0
(0 to 1)
0.4
(0 to 1)
No clinical status score reported - Discharged
22
(19 to 26)
30
(27 to 34)
No clinical status score reported - Discontinued
2
(1 to 3)
4
(2 to 5)
21.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 11
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
8
(6 to 11)
4
(3 to 6)
Hospitalized, on invasive mech. vent. or ECMO
28
(25 to 32)
22
(19 to 26)
Hospitalized, on non-invasive vent./high flow O2
7
(5 to 10)
6
(4 to 8)
Hospitalized, requiring supplemental oxygen
13
(10 to 16)
11
(9 to 14)
Hospitalized, not on O2, requiring ongoing care
6
(5 to 9)
7
(5 to 9)
Hospitalized, not requiring O2, no longer req care
2
(1 to 4)
2
(1 to 4)
Not hospitalized, limit on activities/req home O2
0.4
(0 to 1)
0.4
(0 to 1)
Not hospitalized, no limitations on activities
0.2
(0 to 1)
0
(0 to 1)
No clinical status score reported - Hospitalized
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Discharged
33
(29 to 37)
44
(40 to 48)
No clinical status score reported - Discontinued
2
(1 to 4)
4
(3 to 6)
22.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
11
(9 to 14)
6
(5 to 9)
Hospitalized, on invasive mech. vent. or ECMO
22
(19 to 26)
15
(13 to 19)
Hospitalized, on non-invasive vent./high flow O2
4
(3 to 6)
4
(3 to 6)
Hospitalized, requiring supplemental oxygen
11
(9 to 14)
10
(8 to 13)
Hospitalized, not on O2, requiring ongoing care
6
(5 to 9)
7
(5 to 9)
Hospitalized, not requiring O2, no longer req care
2
(1 to 3)
3
(2 to 4)
Not hospitalized, limit on activities/req home O2
17
(14 to 21)
19
(16 to 22)
Not hospitalized, no limitations on activities
22
(19 to 26)
29
(25 to 33)
No clinical status score reported - Hospitalized
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Discharged
2
(1 to 3)
2
(1 to 4)
No clinical status score reported - Discontinued
3
(2 to 4)
5
(3 to 7)
23.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
13
(10 to 16)
9
(7 to 12)
Hospitalized, on invasive mech. vent. or ECMO
14
(12 to 18)
9
(7 to 12)
Hospitalized, on non-invasive vent./high flow O2
2
(1 to 4)
2
(1 to 4)
Hospitalized, requiring supplemental oxygen
8
(6 to 11)
5
(4 to 8)
Hospitalized, not on O2, requiring ongoing care
5
(4 to 8)
6
(4 to 8)
Hospitalized, not requiring O2, no longer req care
1
(0 to 2)
1
(1 to 3)
Not hospitalized, limit on activities/req home O2
18
(15 to 22)
19
(16 to 23)
Not hospitalized, no limitations on activities
32
(29 to 37)
39
(35 to 43)
No clinical status score reported - Hospitalized
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Discharged
2
(1 to 4)
3
(2 to 5)
No clinical status score reported - Discontinued
4
(2 to 6)
6
(4 to 8)
Completed study without reporting score
0
(0 to 1)
0.2
(0 to 1)
24.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
15
(12 to 18)
11
(8 to 14)
Hospitalized, on invasive mech. vent. or ECMO
9
(7 to 11)
6
(4 to 8)
Hospitalized, on non-invasive vent./high flow O2
2
(1 to 3)
1
(0 to 2)
Hospitalized, requiring supplemental oxygen
4
(3 to 6)
4
(3 to 6)
Hospitalized, not on O2, requiring ongoing care
3
(2 to 5)
3
(2 to 5)
Hospitalized, not requiring O2, no longer req care
1
(0 to 2)
1
(0 to 2)
Not hospitalized, limit on activities/req home O2
19
(16 to 23)
20
(17 to 23)
Not hospitalized, no limitations on activities
36
(32 to 41)
46
(42 to 50)
No clinical status score reported - Hospitalized
0.2
(0 to 1)
0
(0 to 1)
No clinical status score reported - Discharged
3
(2 to 5)
1
(1 to 3)
No clinical status score reported - Discontinued
5
(3 to 7)
7
(5 to 9)
Completed study without reporting score
3
(2 to 4)
2
(1 to 4)
25.Secondary Outcome
Title Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)
Hide Description Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants with available data post baseline, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 516 532
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57
(52.8 to 61.5)
51
(47.0 to 55.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Remdesivir
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments [Not Specified]
Method Barnard's Exact Test
Comments [Not Specified]
26.Secondary Outcome
Title Percentage of Participants Reporting Serious Adverse Events (SAEs)
Hide Description An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants with available data post baseline, analyzed as treated.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 516 532
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32
(27.7 to 35.7)
24
(20.9 to 28.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Remdesivir
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Barnard's Exact Test
Comments [Not Specified]
27.Secondary Outcome
Title Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Hide Description Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses.
Time Frame Day 1 through Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Discontinued due to discharge
30
(26 to 34)
41
(37 to 45)
Discontinued due to death
4
(2 to 6)
3
(2 to 5)
Any infusions halted or slowed
2
(1 to 4)
2
(1 to 4)
Missed any maintenance dose
21
(18 to 25)
16
(13 to 19)
28.Secondary Outcome
Title Duration of Hospitalization
Hide Description Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputation for participants who died Number Analyzed 521 participants 541 participants
17
(8 to 28)
12
(6 to 28)
Restricted to participants who did not die Number Analyzed 443 participants 480 participants
14
(7 to 27)
10
(5 to 21)
29.Secondary Outcome
Title Duration of New Non-invasive Ventilation or High Flow Oxygen Use
Hide Description Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to randomized participants who were not on non-invasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 64 52
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputations for participants who died Number Analyzed 64 participants 52 participants
4
(2 to 23.5)
3
(1 to 10.5)
Among participants who did not die Number Analyzed 50 participants 43 participants
3
(2 to 6)
3
(1 to 6)
30.Secondary Outcome
Title Duration of New Oxygen Use
Hide Description

Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

.

Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to randomized participants who were not on oxygen at baseline but who subsequently required oxygen.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 28 27
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputations for participants who died Number Analyzed 28 participants 27 participants
5.5
(1 to 15)
4
(2 to 12)
Among participants who did not die Number Analyzed 25 participants 24 participants
3
(1 to 13)
3.5
(2 to 5.5)
31.Secondary Outcome
Title Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Hide Description Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline but who subsequently required a ventilator or ECMO.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 82 52
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputations for participants who died Number Analyzed 82 participants 52 participants
23
(12 to 28)
21.5
(9 to 28)
Among participants who did not die Number Analyzed 57 participants 39 participants
16
(9 to 24)
14
(5 to 26)
32.Secondary Outcome
Title Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use
Hide Description New non-invasive ventilation or high-flow oxygen use was determined as the percentage of subject not on non-invasive ventilation or high-flow oxygen at baseline.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to randomized participants who were not on non-invasive or high-flow oxygen at baseline.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 266 307
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24
(19 to 30)
17
(13 to 22)
33.Secondary Outcome
Title Percentage of Participants Requiring New Oxygen Use
Hide Description The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to randomized participants not requiring oxygen at baseline.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 63 75
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44
(33 to 57)
36
(26 to 47)
34.Secondary Outcome
Title Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Hide Description The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 364 402
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23
(19 to 27)
13
(10 to 17)
35.Secondary Outcome
Title Mean Change in the Ordinal Scale
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.
Time Frame Day 1, 3, 5, 8, 11, 15, 22, and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized reporting a clinical score. Missing values were imputed using Last Observation Carried Forward. Clinical scores of 8 were carried forward from the date of death for participants who died.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 518 533
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 3 0.2  (0.6) 0.1  (0.6)
Day 5 0.1  (0.9) 0.0  (0.8)
Day 8 0.0  (0.1) -0.2  (1.0)
Day 11 -0.1  (1.3) -0.3  (1.1)
Day 15 -1.4  (2.3) -1.9  (2.1)
Day 22 -1.9  (2.5) -2.4  (2.2)
Day 29 -2.3  (2.6) -2.7  (2.3)
36.Secondary Outcome
Title 14-day Participant Mortality
Hide Description The mortality rate was determined as the proportion of participants who died by study Day 15.
Time Frame Day 1 through Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consists of all participants as randomized.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.12
(0.09 to 0.15)
0.07
(0.05 to 0.09)
37.Secondary Outcome
Title 29-day Participant Mortality
Hide Description The mortality rate was determined as the proportion of participants who died by study Day 29.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes all participants as randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.15
(0.12 to 0.19)
0.11
(0.09 to 0.15)
38.Secondary Outcome
Title Time to an Improvement by at Least One Category Using an Ordinal Scale
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes all participants as randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Median (95% Confidence Interval)
Unit of Measure: Days
9
(8 to 11)
7
(6 to 8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Remdesivir
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
1.08 to 1.41
Estimation Comments [Not Specified]
39.Secondary Outcome
Title Time to an Improvement of at Least Two Categories Using an Ordinal Scale
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes all participants as randomized
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Median (95% Confidence Interval)
Unit of Measure: Days
14
(13 to 15)
11
(10 to 13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Remdesivir
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
1.12 to 1.48
Estimation Comments [Not Specified]
40.Secondary Outcome
Title Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First
Hide Description The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes all participants as randomized.
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description:
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Median (95% Confidence Interval)
Unit of Measure: Days
12
(10 to 15)
8
(7 to 9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Remdesivir
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
1.10 to 1.46
Estimation Comments [Not Specified]
Time Frame Grade 3 and 4 serious and non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29.
Adverse Event Reporting Description Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. In addition, any Grade 2 or higher, suspected drug-related hypersensitivity reaction was to be reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
 
Arm/Group Title Placebo Remdesivir
Hide Arm/Group Description 200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
All-Cause Mortality
Placebo Remdesivir
Affected / at Risk (%) Affected / at Risk (%)
Total   77/521 (14.78%)      59/541 (10.91%)    
Hide Serious Adverse Events
Placebo Remdesivir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   163/516 (31.59%)      131/532 (24.62%)    
Blood and lymphatic system disorders     
Coagulopathy * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Febrile neutropenia * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Anaemia * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Cardiac disorders     
Cardiac arrest * 1  7/516 (1.36%)  7 10/532 (1.88%)  10
Atrial fibrillation * 1  1/516 (0.19%)  2 5/532 (0.94%)  6
Cardio-respiratory arrest * 1  3/516 (0.58%)  3 1/532 (0.19%)  1
Myocardial infarction * 1  4/516 (0.78%)  4 0/532 (0.00%)  0
Supraventricular tachycardia * 1  3/516 (0.58%)  3 0/532 (0.00%)  0
Ventricular tachycardia * 1  0/516 (0.00%)  0 2/532 (0.38%)  2
Acute myocardial infarction * 1  1/516 (0.19%)  1 1/532 (0.19%)  1
Cardiac failure * 1  1/516 (0.19%)  1 1/532 (0.19%)  1
Cardiogenic shock * 1  2/516 (0.39%)  2 0/532 (0.00%)  0
Acute coronary syndrome * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Arrhythmia * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Palpitations * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Pulseless electrical activity * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Ventricular fibrillation * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Cardiac tamponade * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Gastrointestinal disorders     
Intestinal ischaemia * 1  0/516 (0.00%)  0 3/532 (0.56%)  3
Diarrhoea * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Duodenal perforation * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Gastrointestinal haemorrhage * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Small intestinal perforation * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Haematemesis * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Peptic ulcer haemorrhage * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Small intestinal obstruction * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
General disorders     
Multiple organ dysfunction syndrome * 1  3/516 (0.58%)  3 5/532 (0.94%)  5
Pyrexia * 1  2/516 (0.39%)  2 1/532 (0.19%)  1
Chest pain * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Death * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Hepatobiliary disorders     
Hepatitis * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Ischaemic hepatitis * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Immune system disorders     
Drug hypersensitivity * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Infections and infestations     
Septic shock * 1  15/516 (2.91%)  15 8/532 (1.50%)  8
COVID-19 * 1  5/516 (0.97%)  5 2/532 (0.38%)  2
Bacteraemia * 1  2/516 (0.39%)  2 1/532 (0.19%)  1
COVID-19 pneumonia * 1  2/516 (0.39%)  2 1/532 (0.19%)  1
Sepsis * 1  2/516 (0.39%)  2 1/532 (0.19%)  1
Pneumonia * 1  2/516 (0.39%)  2 0/532 (0.00%)  0
Catheter bacteraemia * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Gangrene * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Infectious pleural effusion * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Staphylococcal bacteraemia * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Urinary tract infection * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Bacterial sepsis * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Endocarditis bacterial * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Injury, poisoning and procedural complications     
Hip fracture * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Infusion related reaction * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Procedural pneumothorax * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Investigations     
Glomerular filtration rate decreased * 1  2/516 (0.39%)  3 5/532 (0.94%)  5
Haemoglobin decreased * 1  2/516 (0.39%)  2 1/532 (0.19%)  1
Oxygen saturation decreased * 1  1/516 (0.19%)  1 1/532 (0.19%)  1
Blood creatinine increased * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Lymphocyte count decreased * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Metabolism and nutrition disorders     
Acidosis * 1  1/516 (0.19%)  1 1/532 (0.19%)  1
Dehydration * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Hypernatraemia * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Hyponatraemia * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Decreased appetite * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain in extremity * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Myalgia * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Myopathy * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident * 1  1/516 (0.19%)  1 3/532 (0.56%)  3
Seizure * 1  1/516 (0.19%)  1 2/532 (0.38%)  2
Cerebellar infarction * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Cerebral haemorrhage * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Encephalopathy * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Subarachnoid haemorrhage * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Depressed level of consciousness * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Haemorrhagic transformation stroke * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Hemiparesis * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Intensive care unit acquired weakness * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Ischaemic stroke * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Psychiatric disorders     
Mental status changes * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Psychotic disorder * 1  1/516 (0.19%)  1 0/532 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury * 1  12/516 (2.33%)  12 7/532 (1.32%)  7
Renal failure * 1  5/516 (0.97%)  5 2/532 (0.38%)  2
Renal impairment * 1  3/516 (0.58%)  3 1/532 (0.19%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory failure * 1  58/516 (11.24%)  59 35/532 (6.58%)  36
Acute respiratory failure * 1  14/516 (2.71%)  14 8/532 (1.50%)  8
Respiratory distress * 1  11/516 (2.13%)  11 6/532 (1.13%)  6
Acute respiratory distress syndrome * 1  5/516 (0.97%)  5 7/532 (1.32%)  7
Pneumothorax * 1  5/516 (0.97%)  5 5/532 (0.94%)  5
Pulmonary embolism * 1  4/516 (0.78%)  4 5/532 (0.94%)  5
Hypoxia * 1  4/516 (0.78%)  4 4/532 (0.75%)  4
Pneumonia aspiration * 1  2/516 (0.39%)  2 4/532 (0.75%)  4
Dyspnoea * 1  1/516 (0.19%)  1 3/532 (0.56%)  3
Respiratory disorder * 1  2/516 (0.39%)  2 0/532 (0.00%)  0
Chronic respiratory failure * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Haemoptysis * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Pulmonary haemorrhage * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Skin and subcutaneous tissue disorders     
Subcutaneous emphysema * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Surgical and medical procedures     
Endotracheal intubation * 1  9/516 (1.74%)  9 6/532 (1.13%)  6
Mechanical ventilation * 1  3/516 (0.58%)  3 1/532 (0.19%)  1
Vascular disorders     
Hypotension * 1  7/516 (1.36%)  7 4/532 (0.75%)  4
Shock * 1  4/516 (0.78%)  4 5/532 (0.94%)  5
Deep vein thrombosis * 1  1/516 (0.19%)  1 1/532 (0.19%)  1
Embolism venous * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Peripheral artery occlusion * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
Shock haemorrhagic * 1  0/516 (0.00%)  0 1/532 (0.19%)  1
1
Term from vocabulary, MedDRA (23.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Remdesivir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   295/516 (57.17%)      276/532 (51.88%)    
Blood and lymphatic system disorders     
Anaemia  1  52/516 (10.08%)  58 42/532 (7.89%)  52
Lymphopenia  1  30/516 (5.81%)  34 13/532 (2.44%)  15
General disorders     
Pyrexia  1  32/516 (6.20%)  37 38/532 (7.14%)  52
Investigations     
Glomerular filtration rate decreased  1  74/516 (14.34%)  81 55/532 (10.34%)  59
Haemoglobin decreased  1  62/516 (12.02%)  69 48/532 (9.02%)  51
Lymphocyte count decreased  1  54/516 (10.47%)  63 44/532 (8.27%)  56
Blood creatinine increased  1  36/516 (6.98%)  41 31/532 (5.83%)  33
Blood glucose increased  1  27/516 (5.23%)  31 39/532 (7.33%)  45
Aspartate aminotransferase increased  1  33/516 (6.40%)  35 18/532 (3.38%)  19
Metabolism and nutrition disorders     
Hyperglycaemia  1  34/516 (6.59%)  43 34/532 (6.39%)  36
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andre Kalil, MD
Organization: University of Nebraska
Phone: 402-559-8650
EMail: akalil@unmc.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04280705    
Other Study ID Numbers: 20-0006
First Submitted: February 20, 2020
First Posted: February 21, 2020
Results First Submitted: September 16, 2020
Results First Posted: September 25, 2020
Last Update Posted: September 25, 2020